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Health Condition(s) or Problem
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Fallopian Tube Cancer; Ovarian Cancer; Malignant Tumor of Peritoneum
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Lay Summary
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RATIONALE: Estrogen may cause the growth of ovarian cancer cells. Hormone therapy using
tamoxifen may fight ovarian cancer by blocking the use of estrogen by the tumor cells.
Measuring CA 125 levels may help doctors predict a patient's response to tamoxifen and help
plan the best treatment.
PURPOSE: This phase II trial is studying CA 125 levels in treating patients with relapsed
advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are
receiving tamoxifen.
(from ClinicalTrials.gov)
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Who can enter the trial
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DISEASE CHARACTERISTICS:
- Histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma, or
primary peritoneal carcinoma
- Completed therapy for first relapse
- Had an elevated CA 125 level before starting relapse therapy with = 50% fall by
completion of that therapy or response according to RECIST criteria
- No significant cancer-related symptoms requiring urgent treatment
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Hemoglobin > 10 g/dL
- WBC > 2,500/mm^3
- Platelet count > 100,000/mm^3
- Creatinine < 2 times upper limit of normal (ULN)
- AST/ALT < 2 times ULN
- Bilirubin < 1.5 times ULN
- No evidence of significant clinical disorder or laboratory finding that would
preclude study participation
- No psychiatric disorder that would preclude informed consent
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- No other concurrent hormonal therapy, except hormone-replacement therapy
- Other concurrent medications allowed provided dose is stable
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Who cannot enter the trial
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DISEASE CHARACTERISTICS:
- Histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma, or
primary peritoneal carcinoma
- Completed therapy for first relapse
- Had an elevated CA 125 level before starting relapse therapy with = 50% fall by
completion of that therapy or response according to RECIST criteria
- No significant cancer-related symptoms requiring urgent treatment
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Hemoglobin > 10 g/dL
- WBC > 2,500/mm^3
- Platelet count > 100,000/mm^3
- Creatinine < 2 times upper limit of normal (ULN)
- AST/ALT < 2 times ULN
- Bilirubin < 1.5 times ULN
- No evidence of significant clinical disorder or laboratory finding that would
preclude study participation
- No psychiatric disorder that would preclude informed consent
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- No other concurrent hormonal therapy, except hormone-replacement therapy
- Other concurrent medications allowed provided dose is stable
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What will happen
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Drug; tamoxifen citrate; Other; laboratory biomarker analysis
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Primary aim
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Percentage of patients who have a log linear rise in CA 125 levels; Comparison of the slope before and after introduction of a new therapy in terms of consistency of the log linear part of the curve; Comparison of the serial doubling time before and after commencing tamoxifen; Number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen
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Secondary Aim
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Sorry, not currently available
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://cancer.gov/clinicaltrials/MTVERNHOSP-CA125
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Recruitment Status
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Recruiting
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Nation
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England, Scotland, Wales
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Location
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Burton upon Trent, Chelmsford, Derby, Guildford, Ipswich, Keighley, Leeds, Liverpool , London, Merseyside , Northwood, Sutton in Ashfield, Oxford, Slough, Southampton, Swindon, Uxbridge, Aberdeen, Glasgow, Bangor, Cardiff, Rhyl, Wrexham
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